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Efficacy and Safety of Empagliflozin (BI 10773) Versus Placebo and Sitagliptin Over 24 Weeks in Patients With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT01177813
Recruitment Status : Completed
First Posted : August 9, 2010
Results First Posted : June 16, 2014
Last Update Posted : June 16, 2014
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 2
Interventions Drug: Placebo identical to BI10773 high dose
Drug: BI 10773
Drug: BI 10773 open label
Drug: Placebo identical to BI10773 low dose
Drug: Placebo identical to Sitagliptin 100mg
Drug: BI10773
Drug: Sitagliptin
Enrollment 986
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Empagliflozin10 mg Empagliflozin 25 mg Sitagliptin 100 mg Empagliflozin 25 mg OL
Hide Arm/Group Description Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning. Patients receive 10 mg Empagliflozin in tablets once daily in the morning. Patients receive 25 mg Empagliflozin in tablets once daily in the morning. Patients receive 100 mg Sitagliptin in tablets once daily in the morning. Patients receive 25 mg Empagliflozin in tablets open label (OL) once daily in the morning.
Period Title: Overall Study
Started 228 224 224 223 87
Completed 187 206 204 206 78
Not Completed 41 18 20 17 9
Reason Not Completed
Adverse Event             8             2             4             6             3
Lack of Efficacy             1             0             0             0             0
Protocol Violation             3             2             2             0             1
Lost to Follow-up             12             5             6             3             0
Withdrawal by Subject             12             7             6             5             3
Other reason not defined above             5             2             2             3             2
Arm/Group Title Placebo Empagliflozin10 mg Empagliflozin 25 mg Sitagliptin 100 Empagliflozin 25 mg OL Total
Hide Arm/Group Description Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning. Patients receive 10 mg Empagliflozin in tablets once daily in the morning. Patients receive 25 mg Empagliflozin in tablets once daily in the morning. Patients receive 100 mg Sitagliptin in tablets once daily in the morning. Patients receive 25 mg Empagliflozin in tablets open label once daily in the morning. Total of all reporting groups
Overall Number of Baseline Participants 228 224 224 223 87 986
Hide Baseline Analysis Population Description
Full analysis set (FAS) including all randomised and treated patients who had a baseline HbA1c value (non-open label groups) and Open-label set including all patients entered in the empagliflozin 25 mg open-label treatment arm.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 228 participants 224 participants 224 participants 223 participants 87 participants 986 participants
54.9  (10.9) 56.2  (11.6) 53.8  (11.6) 55.1  (9.9) 50.2  (11.3) 55.0  (11.0)
[1]
Measure Description: The descriptive statistics for Total refers to the 4 non-open label groups (Placebo, Empagliflozin 10mg and 25 mg, Sitagliptin)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 228 participants 224 participants 224 participants 223 participants 87 participants 986 participants
Female
105
  46.1%
82
  36.6%
79
  35.3%
82
  36.8%
23
  26.4%
371
  37.6%
Male
123
  53.9%
142
  63.4%
145
  64.7%
141
  63.2%
64
  73.6%
615
  62.4%
1.Primary Outcome
Title Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 24 Weeks
Hide Description

The term “baseline” refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm).

In this endpoint, the "measured values" show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive.

Time Frame Baseline and day 169
Hide Outcome Measure Data
Hide Analysis Population Description
FAS and open-label set, last observation carried forward (LOCF) was used as the imputation rule for both sets
Arm/Group Title Placebo Empagliflozin10 mg Empagliflozin 25 mg Sitagliptin 100 mg Empagliflozin 25 mg OL
Hide Arm/Group Description:
Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.
Patients receive 10 mg Empagliflozin in tablets once daily in the morning.
Patients receive 25 mg Empagliflozin in tablets once daily in the morning.
Patients receive 100 mg Sitagliptin in tablets once daily in the morning.
Patients receive 25 mg Empagliflozin in tablets open label once daily in the morning.
Overall Number of Participants Analyzed 228 224 224 223 87
Mean (Standard Error)
Unit of Measure: percent of HbA1c
0.06  (0.05) -0.66  (0.06) -0.77  (0.06) -0.65  (0.05) -3.10  (0.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Empagliflozin10 mg
Comments Model was adjusted for treatment,geographical region, and renal function at baseline as fixed effects, and baseline HbA1c as linear covariate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Difference calculated as empagliflozin 10mg minus placebo
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.74
Confidence Interval (2-Sided) 97.5%
-0.90 to -0.57
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.07
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Empagliflozin 25 mg
Comments Model was adjusted for treatment,geographical region, and renal function at baseline as fixed effects, and baseline HbA1c as linear covariate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Difference calculated as empagliflozin 25mg minus placebo
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.85
Confidence Interval (2-Sided) 97.5%
-1.01 to -0.69
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.07
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline to Week 24 in Body Weight
Hide Description

The term “baseline” refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm).

In this endpoint, the "measured values" show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive.

Time Frame Baseline and day 169
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (LOCF) and open-label set (LOCF)
Arm/Group Title Placebo Empagliflozin10 mg Empagliflozin 25 mg Sitagliptin 100 mg Empagliflozin 25 mg OL
Hide Arm/Group Description:
Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.
Patients receive 10 mg Empagliflozin in tablets once daily in the morning.
Patients receive 25 mg Empagliflozin in tablets once daily in the morning.
Patients receive 100 mg Sitagliptin in tablets once daily in the morning.
Patients receive 25 mg Empagliflozin in tablets open label once daily in the morning.
Overall Number of Participants Analyzed 228 224 224 223 87
Mean (Standard Error)
Unit of Measure: kg
-0.33  (0.15) -2.26  (0.19) -2.48  (0.18) 0.17  (0.18) -1.93  (0.44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Empagliflozin10 mg
Comments Model was adjusted for treatment,geographical region,and renal function at baseline as fixed effects,baseline body weight and baseline HbA1c as linear covariate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Difference calculated as empagliflozin 10mg minus placebo
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.93
Confidence Interval (2-Sided) 97.5%
-2.48 to -1.38
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.24
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Empagliflozin 25 mg
Comments Model was adjusted for treatment,geographical region,and renal function at baseline as fixed effects,baseline body weight and baseline HbA1c as linear covariate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Difference calculated as empagliflozin 25mg minus placebo
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.15
Confidence Interval (2-Sided) 95%
-2.70 to -1.60
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.24
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline to Week 24 in Systolic and Diastolic Blood Pressure (SBP and DBP)
Hide Description

The term “baseline” refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm).

In this endpoint, the "measured values" show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive.

For blood pressure, data following changes in antihypertensive therapy is censored, in the same way that data following initiation of rescue medication is censored.

Time Frame Baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS and open-label set, last observation carried forward without values following a change in antihypertensive therapy (LOCF- H) was used as the imputation rule
Arm/Group Title Placebo Empagliflozin10 mg Empagliflozin 25 mg Sitagliptin 100 mg Empagliflozin 25 mg OL
Hide Arm/Group Description:
Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.
Patients receive 10 mg Empagliflozin in tablets once daily in the morning.
Patients receive 25 mg Empagliflozin in tablets once daily in the morning.
Patients receive 100 mg Sitagliptin in tablets once daily in the morning.
Patients receive 25 mg Empagliflozin in tablets open label once daily in the morning.
Overall Number of Participants Analyzed 228 224 224 223 87
Mean (Standard Error)
Unit of Measure: mmHg
Systolic blood pressure 0.0  (0.8) -3.5  (1.0) -3.2  (0.9) 0.2  (0.9) -3.8  (1.2)
Diastolic blood pressure -0.4  (0.5) -1.1  (0.6) -1.7  (0.5) 0.4  (0.5) -1.5  (0.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Empagliflozin10 mg
Comments

Comparison for Systolic Blood Pressure

Model was adjusted for treatment,geographical region, and renal function at baseline as fixed effects, baseline SBP and baseline HbA1c as linear covariate

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0231
Comments Difference calculated as empagliflozin 10mg minus placebo
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.6
Confidence Interval (2-Sided) 97.5%
-5.2 to 0.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.1
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Empagliflozin 25 mg
Comments

Comparison for Systolic blood pressure

Model was adjusted for treatment,geographical region, and renal function at baseline as fixed effects, baseline SBP and baseline HbA1c as linear covariate

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0028
Comments Difference calculated as empagliflozin 25mg minus placebo
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.4
Confidence Interval (2-Sided) 97.5%
-6.0 to -0.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.1
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Empagliflozin10 mg
Comments

Comparison for diastolic blood pressure

Model was adjusted for treatment,geographical region, and renal function at baseline as fixed effects, baseline DBP and baseline HbA1c as linear covariate

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3987
Comments Difference calculated as empagliflozin 10mg minus placebo
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.6
Confidence Interval (2-Sided) 97.5%
-2.1 to 0.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.7
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Empagliflozin 25 mg
Comments

Comparison for diastolic blood pressure

Model was adjusted for treatment,geographical region, and renal function at baseline as fixed effects, baseline DBP and baseline HbA1c as linear covariate

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0296
Comments Difference calculated as empagliflozin 25mg minus placebo
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.5
Confidence Interval (2-Sided) 97.5%
-3.0 to 0.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.7
Estimation Comments [Not Specified]
4.Other Pre-specified Outcome
Title Confirmed Hypoglycaemic Adverse Events
Hide Description

Confirmed hypoglycaemic events refer to all hypoglycaemic events, that had a glucose value <= 70 ml/dL or where assistance was required.

Symptomatic hypoglycaemic events were to be reported as adverse events. Patients can be counted in more than one category.

Time Frame From first drug intake until 7 days after last medication intake, up to 219 days
Hide Outcome Measure Data
Hide Analysis Population Description
Treated set (actual) including all patients treated with at least 1 dose of randomised trial medication with some treatment switchers (1 from Empa25 to placebo; 1 patient got Empa 10 at least with one mis-allocated kit) and open-label set
Arm/Group Title Placebo Empagliflozin10 mg Empagliflozin 25 mg Sitagliptin 100 mg Empagliflozin 25 mg OL
Hide Arm/Group Description:
Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.
Patients receive 10 mg Empagliflozin in tablets once daily in the morning.
Patients receive 25 mg Empagliflozin in tablets once daily in the morning.
Patients receive 100 mg Sitagliptin in tablets once daily in the morning.
Patients receive 25 mg Empagliflozin in tablets open label once daily in the morning.
Overall Number of Participants Analyzed 229 224 223 223 87
Measure Type: Number
Unit of Measure: percentage of participants
Symptomatic hypoglycaemic adverse events 0.4 0.4 0.4 0.4 0
Asymptomatic hypoglycaemic adverse events 0 0 0 0 0
Time Frame From first drug administration until seven days after last trial medication intake, up to 219 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Empagliflozin10 mg Empagliflozin 25 mg Sitagliptin 100 mg Empagliflozin 25 mg OL
Hide Arm/Group Description Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning. Patients receive 10 mg Empagliflozin in tablets once daily in the morning. Patients receive 25 mg Empagliflozin in tablets once daily in the morning. Patients receive 100 mg Sitagliptin in tablets once daily in the morning. Patients receive 25 mg Empagliflozin in tablets open label (OL) once daily in the morning.
All-Cause Mortality
Placebo Empagliflozin10 mg Empagliflozin 25 mg Sitagliptin 100 mg Empagliflozin 25 mg OL
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Empagliflozin10 mg Empagliflozin 25 mg Sitagliptin 100 mg Empagliflozin 25 mg OL
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/229 (2.62%)   8/224 (3.57%)   5/223 (2.24%)   6/223 (2.69%)   3/87 (3.45%) 
Cardiac disorders           
Angina unstable  1  0/229 (0.00%)  0/224 (0.00%)  0/223 (0.00%)  0/223 (0.00%)  1/87 (1.15%) 
Acute myocardial infarction  1  0/229 (0.00%)  0/224 (0.00%)  1/223 (0.45%)  0/223 (0.00%)  0/87 (0.00%) 
Atrial fibrillation  1  0/229 (0.00%)  0/224 (0.00%)  0/223 (0.00%)  1/223 (0.45%)  0/87 (0.00%) 
Myocardial infarction  1  1/229 (0.44%)  0/224 (0.00%)  0/223 (0.00%)  0/223 (0.00%)  0/87 (0.00%) 
Congenital, familial and genetic disorders           
Gilbert's syndrome  1  1/229 (0.44%)  0/224 (0.00%)  0/223 (0.00%)  0/223 (0.00%)  0/87 (0.00%) 
Endocrine disorders           
Goitre  1  0/229 (0.00%)  0/224 (0.00%)  1/223 (0.45%)  0/223 (0.00%)  0/87 (0.00%) 
Eye disorders           
Cataract  1  0/229 (0.00%)  1/224 (0.45%)  0/223 (0.00%)  0/223 (0.00%)  0/87 (0.00%) 
Gastrointestinal disorders           
Colonic polyp  1  0/229 (0.00%)  0/224 (0.00%)  0/223 (0.00%)  1/223 (0.45%)  0/87 (0.00%) 
Haemorrhoids  1  0/229 (0.00%)  1/224 (0.45%)  0/223 (0.00%)  0/223 (0.00%)  0/87 (0.00%) 
General disorders           
Hernia  1  0/229 (0.00%)  0/224 (0.00%)  0/223 (0.00%)  1/223 (0.45%)  0/87 (0.00%) 
Hepatobiliary disorders           
Cholecystitis  1  0/229 (0.00%)  0/224 (0.00%)  0/223 (0.00%)  1/223 (0.45%)  0/87 (0.00%) 
Cholecystitis acute  1  1/229 (0.44%)  0/224 (0.00%)  0/223 (0.00%)  1/223 (0.45%)  0/87 (0.00%) 
Liver disorder  1  0/229 (0.00%)  1/224 (0.45%)  0/223 (0.00%)  0/223 (0.00%)  0/87 (0.00%) 
Infections and infestations           
Herpes virus infection  1  0/229 (0.00%)  1/224 (0.45%)  0/223 (0.00%)  0/223 (0.00%)  0/87 (0.00%) 
Injury, poisoning and procedural complications           
Soft tissue injury  1  0/229 (0.00%)  0/224 (0.00%)  0/223 (0.00%)  0/223 (0.00%)  1/87 (1.15%) 
Animal bite  1  0/229 (0.00%)  1/224 (0.45%)  0/223 (0.00%)  0/223 (0.00%)  0/87 (0.00%) 
Injury  1  0/229 (0.00%)  1/224 (0.45%)  0/223 (0.00%)  0/223 (0.00%)  0/87 (0.00%) 
Tendon rupture  1  0/229 (0.00%)  1/224 (0.45%)  0/223 (0.00%)  0/223 (0.00%)  0/87 (0.00%) 
Tibia fracture  1  0/229 (0.00%)  0/224 (0.00%)  1/223 (0.45%)  0/223 (0.00%)  0/87 (0.00%) 
Metabolism and nutrition disorders           
Hyperglycaemia  1  1/229 (0.44%)  0/224 (0.00%)  0/223 (0.00%)  0/223 (0.00%)  0/87 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Breast cancer female  1  0/229 (0.00%)  1/224 (0.45%)  0/223 (0.00%)  0/223 (0.00%)  0/87 (0.00%) 
Colon cancer  1  1/229 (0.44%)  0/224 (0.00%)  0/223 (0.00%)  0/223 (0.00%)  0/87 (0.00%) 
Lung neoplasm malignant  1  0/229 (0.00%)  0/224 (0.00%)  1/223 (0.45%)  0/223 (0.00%)  0/87 (0.00%) 
Metastases to central nervous system  1  0/229 (0.00%)  0/224 (0.00%)  1/223 (0.45%)  0/223 (0.00%)  0/87 (0.00%) 
Nervous system disorders           
Diabetic neuropathy  1  1/229 (0.44%)  0/224 (0.00%)  0/223 (0.00%)  0/223 (0.00%)  1/87 (1.15%) 
Cerebrovascular accident  1  0/229 (0.00%)  1/224 (0.45%)  0/223 (0.00%)  0/223 (0.00%)  0/87 (0.00%) 
Ischaemic stroke  1  1/229 (0.44%)  0/224 (0.00%)  0/223 (0.00%)  0/223 (0.00%)  0/87 (0.00%) 
Transient ischaemic attack  1  0/229 (0.00%)  0/224 (0.00%)  0/223 (0.00%)  1/223 (0.45%)  0/87 (0.00%) 
Vertebrobasilar insufficiency  1  0/229 (0.00%)  0/224 (0.00%)  0/223 (0.00%)  1/223 (0.45%)  0/87 (0.00%) 
Reproductive system and breast disorders           
Benign prostatic hyperplasia  1  0/229 (0.00%)  0/224 (0.00%)  0/223 (0.00%)  1/223 (0.45%)  0/87 (0.00%) 
Breast mass  1  0/229 (0.00%)  0/224 (0.00%)  1/223 (0.45%)  0/223 (0.00%)  0/87 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Chronic obstructive pulmonary disease  1  0/229 (0.00%)  0/224 (0.00%)  0/223 (0.00%)  1/223 (0.45%)  0/87 (0.00%) 
Hypercapnia  1  0/229 (0.00%)  0/224 (0.00%)  0/223 (0.00%)  1/223 (0.45%)  0/87 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Empagliflozin10 mg Empagliflozin 25 mg Sitagliptin 100 mg Empagliflozin 25 mg OL
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   63/229 (27.51%)   45/224 (20.09%)   36/223 (16.14%)   44/223 (19.73%)   27/87 (31.03%) 
Gastrointestinal disorders           
Diarrhoea  1  3/229 (1.31%)  4/224 (1.79%)  3/223 (1.35%)  3/223 (1.35%)  6/87 (6.90%) 
Infections and infestations           
Nasopharyngitis  1  17/229 (7.42%)  16/224 (7.14%)  11/223 (4.93%)  15/223 (6.73%)  1/87 (1.15%) 
Urinary tract infection  1  9/229 (3.93%)  14/224 (6.25%)  8/223 (3.59%)  11/223 (4.93%)  3/87 (3.45%) 
Metabolism and nutrition disorders           
Hyperglycaemia  1  35/229 (15.28%)  5/224 (2.23%)  4/223 (1.79%)  13/223 (5.83%)  14/87 (16.09%) 
Dyslipidaemia  1  10/229 (4.37%)  13/224 (5.80%)  10/223 (4.48%)  6/223 (2.69%)  7/87 (8.05%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 14.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Results Point of Contact
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01177813     History of Changes
Other Study ID Numbers: 1245.20
2009-016243-20 ( EudraCT Number: EudraCT )
First Submitted: July 29, 2010
First Posted: August 9, 2010
Results First Submitted: May 16, 2014
Results First Posted: June 16, 2014
Last Update Posted: June 16, 2014